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The intended use of the Winco Model S550 Stretchair is to provide a method of transporting patients within healthcare facilities.

The Winco Model S550 Stretchair is a battery powered device designed for use in healthcare facilities. Its' intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.

The Winco Model S550 Stretchair has a powered height adjustment feature which allows patient surface to be raised and lowered for patient mounting and patient access. It also has a powered linear actuator which changes the patient surface from a sitting position to a laying (supine) position.

The patient can be transported only when in the seated position. When in the supine position, it can be used to transfer a patient to/from a bed, gurney or other patient support surface. The Winco Model S550 Stretchair is for patients weighing up to 550 Ibs. It is intended for indoor use only, by trained medical staff and health care personnel. There is no drive mechanism or power assist for moving the product from one physical location to another. This is performed manually by the medical staff. The device cannot be self-propelled by the patient.

The provided documents are a 510(k) premarket notification for a medical device (Winco Model S550 Stretchair). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than showcasing a new device's performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the following information regarding acceptance criteria and a study proving the device meets them:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results or effect sizes.
6. Standalone performance study results for an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document focuses on:

• Device Description: Details the functionality and components of the Winco Model S550 Stretchair.
• Predicate Device: Identifies the Winco Stretchair Model S999 (K110671) as the predicate.
• Comparison of Technological Characteristics: Discusses similarities and differences between the new device and the predicate, emphasizing that differences (like weight capacity and width) do not affect safety, effectiveness, or substantial equivalence.
• Performance Data (Standards Conformance): States that the Winco Model S550 Stretchair meets general safety and essential performance standards:
  • IEC 60601-1 Medical Electrical Equipment Part 1: General Requirement for Safety
  • IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
• Conclusion: Asserts substantial equivalence based on identical technology, principle of operation, indications for use, and conformance to the same safety standards as the predicate device. The document explicitly states, "Performance testing and use of the same identical lift mechanism and linear actuator supports the safety of the Winco Model S550 Stretchair. Since the predicate was cleared in part on these data, conformance with the same requirements demonstrates that the Winco Model S550 Stretchair will perform as intended in the specified use conditions."

In summary, the provided text describes a mechanical device cleared via the 510(k) pathway, which primarily relies on demonstrating equivalence to an existing device and adherence to relevant industry standards, not on clinical performance studies with acceptance criteria in the way an AI/software device often would.

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The Prime Series® Stretcher with Zoom® Motorized Drive is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications, such as short-term outpatient clinical evaluation, treatment, minor procedure, and as a short-term outpatient recovery platform. The drive-assist Zoom® feature provides a healthcare professional and/or trained representative greater maneuverability in steering and moving the stretcher with significantly less force. The Prime Series® Stretcher with Zoom® Motorized Drive is intended for use in all establishments and may include use in, but not limited to, the Emergency Department (ED), including the Trauma area, and Postanesthesia Care Unit (PACU). The Prime Series® Stretcher with Zoom® Motorized Drive has a safe working load up to 700 pounds (318 kg) and is intended to support and transport all patients, including those mildly to critically ill. The Prime Series® Stretcher with Zoom® Motorized Drive may also be used to transport deceased patients within an enclosed healthcare facility.

The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The Prime Series® Stretcher with Zoom® Motorized Drive, is a powered wheeled stretcher that consists of a platform mounted on a wheeled frame that is designed to transport patients in a substantially horizontal position within the interior of a healthcare facility by health professionals and/or trained representatives of the user facility. The electric-drive system, called the Zoom Drive System, assists the health professional and/or trained representative by assisting stretcher movement and maneuverability in various healthcare facilities. The device can be manually pushed by the user in the event of power loss to the Zoom Drive System. The device has siderails, supports for fluid infusion equipment, and various options and accessories that assist with the transport of the patient. The Prime X option is intended to provide an articulating radiographic patient support surface and a platform below the patient support surface for x-ray cassette placement to assist in the capture of clinical x-rays when used in conjunction with a medical x-ray system.

The provided text describes the Stryker Prime Series® Stretcher with Zoom® Motorized Drive, and its acceptance criteria are primarily demonstrated through substantial equivalence to a predicate device and verification and validation (V&V) testing to ensure safety and effectiveness.

Here's a breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" in the format of defined thresholds with corresponding "device performance" results. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device and passing functional, performance, safety, and efficacy specifications through V&V testing. The reported device performance is largely a direct comparison to the predicate device, indicating that the new device performs at least as well as the predicate and meets relevant standards.

Here's an attempt to extract and present the closest information to your request, focusing on comparative aspects and testing outcomes:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Physical and mechanical testing has been performed on individual components and on the system" and "bench and software testing." However, it does not specify the sample size for these tests. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). Given the nature of a 510(k) submission for a physical medical device like a stretcher, the testing would be considered prospective as it's conducted specifically for demonstrating compliance before market approval.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the document describes a physical medical device (a stretcher), not an AI/diagnostic software. "Ground truth" in the context of expert consensus is typically relevant for evaluating diagnostic accuracy, which is not the primary concern for a patient transport stretcher. The "truth" in this context is defined by engineering specifications and recognized performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reason as point 3. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers in diagnostic studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a motorized stretcher, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study and effect size in improving human reader performance with AI is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. There is no algorithm in the sense of an AI or diagnostic software being evaluated. The "Zoom Motorized Drive" is an electromechanical system that assists a human caregiver. Its performance is always "human-in-the-loop" as it requires a caregiver to operate it.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by engineering specifications, performance standards (e.g., IEC, ISO, AAMI), and predefined functional requirements. These are generally objective, measurable parameters rather than subjective expert consensus, pathology, or outcomes data. For example, the "ground truth" for patient capacity (700 lbs max) would be determined by structural integrity tests and engineering calculations.

8. The sample size for the training set

This is not applicable. This is a physical electromechanical device, not a machine learning model that requires a "training set" of data.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

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The Hill-Rom® Procedural Stretcher with Intellidrive® is intended to assist caregivers in the treatment and transportation of patients in all areas of hospitals, surgical centers, and other patient care facilities. The Intellidrive™ Transport System is permanently attached powered drive that is assembled into the existing Procedural Stretcher model. This feature lets the caregiver move the stretcher forward or reverse with very little applied force. The caregiver operates the system through the transport handles.

The Hill-Rom Procedural Stretcher product is a movable, castermounted stretcher. The product has side rails, supports for fluid infusion equipment, and a scale for weighing patients. A twin-hydraulic cylinder lift system provides support, height adjustment and Trendelenburg features for the patient surface. The stretcher is available with an optional that consists of the addition of a battery-powered drive mechanism which is integrated into the stretcher platform provides propulsion of the platform along the floor with minimal force applied by the caregiver. The powered drive mechanism is only controllable by the caregiver and not the patient. The Intellidrive® option aids in the transportation of patients by providing healthcare personnel with the ability to more easily move and maneuver the stretcher.

The provided text describes a medical device, the Hill-Rom Procedural Stretcher with Intellidrive®, and its 510(k) summary for substantial equivalence review by the FDA. This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with a ground truth as would typically be done for a novel AI/ML device.

Therefore, the information requested in your prompt (e.g., acceptance criteria, reported device performance in a table, sample size for test set, expert qualifications, adjudication methods, MRMC study, standalone performance, type of ground truth, training set details) is not applicable in the context of this 510(k) submission for a mechanical medical device like a stretcher with a powered drive.

Here's why and what information is available in the provided text:

• Acceptance Criteria and Reported Device Performance: Not presented in the context of a clinical study with specific performance metrics. Instead, the submission focuses on meeting safety standards and demonstrating substantial equivalence to a predicate device. The "performance" is implicitly deemed acceptable if it meets the design requirements and voluntary standards.

• Sample Size for Test Set and Data Provenance: Not applicable. The "testing" referred to is engineering verification and validation (V&V) against design requirements and safety standards, not a clinical study involving a dataset of patient cases.

• Experts and Qualifications for Ground Truth: Not applicable. There's no "ground truth" in the sense of expert-reviewed medical images or patient outcomes for this type of device submission.

• Adjudication Method: Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is relevant for diagnostic devices, especially those with AI assistance, not for a powered stretcher.

• Standalone Performance: Not applicable.

• Type of Ground Truth Used: Not applicable. The "ground truth" for this device's safety and effectiveness is established by meeting engineering design specifications, applicable safety standards (like IEC 60601 series, UL 60601-1, CAN/CSA C22.2 601.1-M90), and demonstrating equivalence to a predicate device.

• Sample Size for Training Set & How Ground Truth for Training Set was Established: Not applicable. This device does not involve machine learning or artificial intelligence in the way a diagnostic imaging device would. Therefore, there's no "training set" in the context of AI/ML.

What the document does provide regarding device evaluation:

• Verification and Validation Plan: The document states that a "verification and validation plan has been developed that defines the testing parameters that ensure that the product meets its design requirements and that the hazards that were identified were eliminated by design features or that the occurrence rate is as low as reasonably possible." This includes system-level and module-level testing.
• Voluntary Standards Met: The device successfully meets several electrical safety and electromagnetic compatibility (EMC) standards:
  • IEC 60601-1 (Electrical Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • UL 60601-1
  • CAN/CSA C22.2 601.1-M90
  • IEC 60601-1-4 (Programmable electrical medical systems)
  • IEC 60601-2-38 (Electrically operated hospital beds)
• Comparison to Predicate Device: The submission demonstrates substantial equivalence to the Stryker Powered Wheeled Stretcher (#K022309) in terms of function, intended use, classification, basic technology, and performance characteristics. Hazards were identified and evaluated, including a review of complaints and recalls for similar products.

In summary, the provided document is a 510(k) submission for a mechanical medical device, not an AI/ML-powered diagnostic device. Therefore, the questions related to clinical study design, ground truth, and AI-specific performance metrics are not relevant to this submission.

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The intended use of the Winco Stretchair is to provide a method of transporting patients within healthcare facilities.

The Winco Mfg., LLC Stretchair is a battery powered device designed for use in healthcare facilities. Its intended function and use is to transport patients within the confines of the healthcare facility, where patient care is being administered. It can also be used to support the patient during examinations and other clinical activity which may take place in the facility.

The Stretchair can support a patient in either a supine (laying) position or seated position. The Stretchair model S300 is for patients weighing up to 300 lbs, the S675 is for patients weighing up to 675 lbs, and the S999 is for patients weighing up to 1000 lbs.

The product includes a battery powered linear actuator to lower the backrest and raise the footrest simultaneously. It also includes a hydraulic unit for vertical height adjustment.

This is a submission for a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with acceptance criteria based on performance metrics. Therefore, many of the requested categories for AI/algorithm performance studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a medical device submission for a physical product (a stretcher), not an AI/algorithm-based device. Performance was assessed against electrical safety and flame retardancy standards, not through clinical data sets.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a medical device submission for a physical product. "Ground truth" in the context of AI/algorithm performance is not relevant here. Compliance with standards is typically verified by certified testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. The evaluation was based on compliance with established safety and material standards, not on expert consensus or adjudication of a test set in the AI sense.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a powered wheeled stretcher, not an AI or imaging diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical product; there is no algorithm or standalone performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" in this context is the fulfillment of requirements outlined in recognized safety and material standards:

• UL 60601-1 and CAN/CSA C 22.2 Electrical Safety Standards
• CAL 117 for Flame Retardancy

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device submission.

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The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.

The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.

The provided text describes a 510(k) summary for the HoverTech International® Transformer, a battery-powered patient transport device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.

Here's why and what information is missing:

• Acceptance Criteria and Reported Device Performance: The document states that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." However, it does not list what those specific specifications or acceptance criteria are, nor does it provide the results or reported performance of the device against them. It only mentions compliance with voluntary standards like IEC and UL for safety and biocompatibility. These are general standards, not specific performance metrics for this particular device.
• Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set: All of these data points are typical for studies evaluating diagnostic or predictive algorithms/devices, especially in fields like medical imaging. Since the HoverTech International® Transformer is a physical patient transport device (a powered wheeled stretcher), these types of studies (MRMC, standalone algorithm performance, training/test sets for AI, ground truth establishment by experts/pathology) are not applicable to this device's regulatory submission as described.

Summary of missing information:

1. Table of acceptance criteria and reported device performance: Not provided. The document generally states "compliance with specifications" and "safety testing," but no specific metrics or results are reported.
2. Sample size used for the test set and data provenance: Not applicable in the context of this physical device.
3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What is present in the document is a declaration of compliance with general safety and electrical standards:

• Voluntary Standards the device will comply with:
  • IEC 60601-1 (General Requirements for Safety)
  • IEC 60601-1-2 (Electromagnetic Compatibility)
  • IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds - applicable parts only for loading and pinch points)
  • UL 2601-1 (Standard for Medical Electrical Equipment)
  • CAN/CSA C22.2 No. 601.1-M90 (Standard for Medical Equipment)
  • ISO 10993-5 (Biocompatibility - In Vitro cytotoxicity)
  • ISO 10933-10 (Biocompatibility - irritation and sensitization, delayed type hypersensitivity)

The document concludes that the device is "substantially equivalent" to a predicate device (Transmotion Medical Model TMM6 Power Drive Chair) based on "intended use, basic technology, and performance characteristics." The "performance characteristics" are implied to be met through the safety testing and compliance with the listed voluntary standards, but no specific performance data is disclosed in this summary.

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The TransMotion Medical Model TMM6 Power Drive Chair is intended to provide a method of transporting patients within health care facilities.
The TransMotion Medical TMM6 Power Drive Chair is designed for use in short term (≤ 23 hours) health care facilities. Its' intended use is to provide a method of transporting patients within the facility.

The TransMotion Medical, Inc. TMM6 Power Drive Chair (TMM6) is a battery powered device designed for use in short term (≤ 23 hours) patient care facilities. Its intended function and use is to transport patients within the confines of the facility, where patient function and use is to transport patient used to support the patient during examinations, care is boing administer clinical activity which may take place in the facility.
The TMM6 is unique in that it can support and transport patients in either a supine The TMMO is unique in that it can supportures 1 and 2 below). This enhances patient (laying) poregivers and also provides for greater patient comfort.

The provided 510(k) Premarket Notification for the TransMotion Medical TMM6 Power Drive Chair does not contain the detailed information necessary to complete most of the requested table and study details. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed performance study with acceptance criteria and specific test results from a clinical trial.

Here's an analysis of what information can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Missing from the document concerning acceptance criteria and performance:

• Quantitative performance metrics: The document lacks specific, measurable acceptance criteria for aspects like battery life, weight capacity, maneuverability, braking effectiveness, stability, patient comfort scores, or reliability data.
• Actual test results: While it states "compliance" with standards, detailed results demonstrating this compliance (e.g., EMC emission levels, safety test outcomes) are not provided.

2. Sample size used for the test set and the data provenance

• Sample size for test set: Not applicable/not provided. This 510(k) submission primarily relies on demonstrating compliance with voluntary standards and substantial equivalence to a predicate device, not on clinical performance data from a specific test set of patients or users.
• Data provenance: Not applicable/not provided. There is no mention of country of origin or whether data would be retrospective or prospective because a clinical study with a test set as commonly understood for AI/diagnostic devices was not performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. There is no mention of a test set requiring ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not applicable. No test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This device is a powered patient transport chair, not an AI-assisted diagnostic or operative device that would involve human "readers" or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable. This device does not generate diagnostic output that requires ground truth validation. The "truth" in this context is the chair's ability to safely and effectively perform its stated functions, which would be assessed through engineering and safety testing against defined specifications.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established

• Not applicable.

Summary of Device and Approval Process:

The TransMotion Medical TMM6 Power Drive Chair is a battery-powered device designed for transporting patients within healthcare facilities for short durations (≤ 23 hours). It can support patients in both supine and seated positions. The 510(k) submission primarily establishes substantial equivalence to a predicate device, the Stryker Powered Wheeled Stretcher (K022309), and states compliance with IEC 60601-1 (General Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) standards. The FDA's letter confirms that based on the provided information, the device is substantially equivalent, permitting its marketing. The approval process for such a device would heavily rely on engineering testing to confirm safety, electrical performance, mechanical integrity, and functional performance against its design specifications and relevant voluntary standards. Clinical trials or performance studies with patient outcomes data, as might be seen for novel diagnostic or therapeutic devices, are not typically required for this type of device seeking 510(k) clearance based on substantial equivalence.

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the device is a motorized device intended for medical purposes to assist in transfer of patient to and from beds, chairs, treatment facilities. wheelchairs or transport vehicles.

the Savion Industries "Medi-Cruiser" model MS777 Stretcher is a motorized patient transport stretcher / trolley. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.

The provided text is for a 510(k) summary for a "Motorized Patient Transport Stretcher" (Savion Industries "Medi-Cruiser" Model MS777). This type of device is a physical medical instrument, not a software device or an AI model, and therefore the concepts of acceptance criteria, study data, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable in the way they would be for an AI/ML medical device.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices and compliance with safety standards for electrical and electromagnetic compatibility, as well as quality systems regulations.

Here's how to interpret the provided information in the context of a non-AI medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance:

For this device, "acceptance criteria" and "reported device performance" are primarily related to compliance with recognized medical device standards and demonstrating equivalence to existing legally marketed devices, rather than statistical performance metrics like sensitivity or specificity.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not applicable. For a physical device like a stretcher, performance is evaluated through engineering tests (e.g., electrical safety, EMC, mechanical load testing) rather than a "test set" of data points. These tests typically involve a specific number of units from the production line or prototypes to verify compliance with standards. The document doesn't specify the number of units tested.
• Data Provenance: Not applicable in the context of an AI/ML device. The "data" here refers to test results from physical device testing, which would be generated in a lab setting, likely in Israel (where Savion Industries is located) or by an accredited international testing body. It's a prospective testing process on physical devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

• Number of Experts & Qualifications: Not applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on images) is not relevant for this device. The "truth" is established by adherence to engineering performance standards and regulatory requirements. The "experts" involved would be the engineers performing the tests, the quality assurance team, and the regulatory affairs personnel ensuring compliance. A design review was conducted by a "cross-functional team, including but not limited to regulatory, quality, engineering, technical writing and manufacturing."

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no ambiguous "ground truth" that requires adjudication. Tests either pass or fail based on objectively defined criteria in the standards (e.g., leakage current levels, mechanical stability).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: Not applicable. MRMC studies are used to evaluate the performance of diagnostic devices, often AI-assisted, by comparing human reader performance with and without AI assistance across multiple cases. This is a motorized stretcher, a therapeutic/transport device, not a diagnostic one.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Standalone Performance: Not applicable. This is a physical medical device. There is no algorithm or AI component to assess for standalone performance. The "device" itself operates with human interaction (caregivers).

7. The Type of Ground Truth Used:

• Type of Ground Truth: Not applicable in the AI/ML sense. For this device, the "ground truth" is defined by:
  • Regulatory Standards: (e.g., IEC 60601-1, IEC 60601-1-2, UL 2601-1, CAN/CSA C22.2 No. 601.1-M90, FDA 21 CFR 820.30, ISO 9001:2000, ISO 13485).
  • Predicate Device Performance: The "truth" of what is safe and effective is established by the existing, legally marketed predicate devices to which the new device demonstrates substantial equivalence.
  • Engineering Specifications: Internal design and performance specifications against which the device is tested.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. There is no "training set" for a physical medical device in the AI/ML context. The design and manufacturing process are informed by engineering principles, industry best practices, and regulatory standards, not by machine learning training data.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable. As there's no training set, there's no associated ground truth to establish.

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The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified powered patient transports as a Class II device.

The Hausted® POWERTRAN™ Series Stretcher is a powered patient transport. This device is a motorized device intended for medical purposes to assist in the transfer of patients to and from the bath, beds, chairs, treatment modalities, and transport vehicles. The FDA has classified the device as a Class II device. The FDA has classified powered patient transports as a Class II device.

The Hausted® POWERTRAN™ Series Stretcher is designed to assure compliance with IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). The device will also carry the ETL (to UL 2601-1) and cETL (to CAN/CSA C22.2 No. 601.1-M90) markings. Electrical testing will be certified by the accredited testing facility shown at the end of this certification. Software testing is being certified by STERIS as the manufacturer.

The provided text is a 510(k) summary for a medical device called "The Hausted® POWERTRAN™ Series Stretcher." This document describes a submission for regulatory clearance, not a study that proves the device meets acceptance criteria in the way clinical studies for AI/diagnostic devices do.

Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test/training sets, ground truth establishment, expert qualifications, MRMC studies, and standalone performance) are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and how "proof" is presented in this context, which is primarily through safety and performance testing against recognized standards and comparison to predicate devices.

Acceptance Criteria and Reported Device Performance

Non-Applicable / Not Provided Information for AI/Diagnostic Device Studies:

2. Sample size used for the test set and the data provenance: Not applicable. This is a physical medical device, not an AI/diagnostic software. Testing involves physical device evaluations against engineering standards, not data sets for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's safety and performance is established by compliance with engineering and safety standards, and by comparison to predicate devices, not by expert consensus on data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device like a stretcher, "ground truth" relates to engineering specifications and compliance with recognized safety standards (like IEC, UL, CSA). It means the device physically meets the requirements set forth in those standards and performs its intended function safely, as demonstrated through testing and design reviews.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of "Study" (in this context):

The "study" or rather, the evidence presented for this 510(k) submission, is a comprehensive set of safety and performance characteristic tests conducted by the manufacturer (STERIS) and certified by accredited testing facilities. These tests ensure compliance with various national and international electrical, electromagnetic compatibility (EMC), and general safety standards (IEC 60601-1, IEC 60601-1-2, UL 2601-1, CAN/CSA C22.2 No. 601.1-M90). Additionally, a risk assessment and design review process (following ISO 9001 principles) were conducted by a cross-functional team. The core of the 510(k) argument is the demonstration of substantial equivalence to already legally marketed predicate devices (Stryker ZOOM® Motorized Stretchers and Stryker Powered Wheeled Stretcher) in terms of intended use, basic technology, and performance characteristics. The minor differences were deemed not to raise any new issues of safety or effectiveness.

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The Stryker Powered Wheeled Stretcher is an electromechanical stretcher that provides a method of transporting patients within healthcare facilities. The stretcher may be used for minor procedures and short-term stay, typical of existing stretcher applications.
The drive-assist Big Wheel provides the healthcare caregiver greater maneuverability in steering and moving the stretcher with significantly less force.

The Stryker Powered Wheeled Stretcher is a powered patient transport device with a motorized drive-assist fifth wheel. This stretcher is a motorized device to be used to transport patients with the many contract, and patient securement straps. The stretcher will have a motorized drive-assist fifth wheel that will assist the caregiver in maneuvering the stretcher. Only the caregiver, not the patient, will have controls to adjust patient positioning. As with the predicate device, the stretcher of this submission will be a movable, caster mounted stretcher. In addition, as with the predicate stretcher, the lift system provides both support and height and life surface to the patient surface. The stretcher is designed to meet UL and IEC stability requirements.

The provided text is a 510(k) premarket notification for the Stryker Powered Wheeled Stretcher. It focuses on demonstrating substantial equivalence to a predicate device and outlines general safety and performance characteristics, but it does not contain specific acceptance criteria, study data, or detailed performance results in the format requested.

Therefore, the following information is not present in the provided document:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set, data provenance, number of experts, and adjudication methods for ground truth establishment.
3. Information on multi-reader multi-case (MRMC) comparative effectiveness studies or standalone performance studies.
4. Specific type of ground truth used (e.g., pathology, outcomes data).
5. Sample size for the training set and how its ground truth was established.

What the document does provide in relation to performance and testing is:

• General Statement about Testing: "Significant safety and performance characteristics are tested to ensure compliance with specifications. After testing is complete, the test reports become part of the Device Master Record."
• Risk Management: "A review of risks and hazards of the product was conducted. This included complaints, recalls, and medical device reports analyses. Also, a review was also conducted to identify other device reports and performance hazards by a cross-functional team... A verification and validation plan has been developed to ensure these hazards have been considered and their occurrence minimized."
• Compliance with Voluntary Standards: The device will comply with several voluntary standards related to medical electrical equipment safety and electromagnetic compatibility (IEC 601-1-1, IEC 601-1-2, UL 2601-1, CAN/CSA-C22.2 No. 601.1-M90). These standards typically involve specific tests and acceptance criteria, but the document does not elaborate on the specific results from those tests.

In summary, this document is a regulatory submission for substantial equivalence based on safety characteristics and compliance with general standards, rather than a detailed clinical or performance study report with explicit acceptance criteria and results for the device's functional performance.

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